Automated insertion device for heart valve prosthesis

ABSTRACT

The invention concerns an automated ancillary device ( 100 ) for inserting and fixing by means of clips an annular body ( 200 ), namely a prosthesis, on a annular resilient volume ( 23 ) including, coaxial about an axis (D), means for receiving and supporting ( 8 ) said body ( 200 ) coaxial to its axis, means for radially unfolding ( 500 ) about said axis (D) articulated supports ( 4 ) capable of bearing clips ( 21 ), the latter being capable of passing through both a thickness of material belonging to such a volume ( 23 ) and a thickness of material belonging to said body ( 200 ), under the action of means for longitudinally pushing ( 600 ) said supports ( 4 ) with respect to said means for receiving and supporting ( 8 ). 
     It includes means for gripping ( 300 ) material of the volume ( 23 ) capable of radially retracting said material. The means for radially unfolding ( 500 ) are capable of moving said clips ( 21 ) parallel to said axis (D).

BACKGROUND OF THE INVENTION

(1) Field of the Invention

The invention relates to an automated ancillary device for inserting andfixing a prosthetic cardiac valve.

The present invention relates to the field of the surgery tools.

The invention relates more particularly to an automated ancillary devicefor inserting and fixing a prosthetic cardiac valve. A prostheticcardiac valve is a prosthesis with a circular or annular shape, which isimplanted instead of a patient's heart valve, in particular an aorticvalve or a mitral valve.

The surgical operation during which the practitioner resects, i.e. cutsand removes the patient's native valve or valves so that only thepatient's ring remains, i.e. an annular surface belonging to the heartto which the prosthetic valve will be fixed, then implants and fixes aprosthetic cardiac valve, is long and delicate. Indeed, in order tocarry out a replacement of a natural valve by a prosthetic valve it isnecessary to bring about an extra-corporal circulation of the patient'sblood. It is interesting to reduce to a minimum the duration of thisextra-corporal circulation, which is not good for the patient. Indeed,an extended duration can cause particular clinical complications.

The invention thus proposes to put at the disposal of the heart-surgerypractitioners an ancillary device, which permits them to considerablyreduce the duration of the operation, so as to reduce the risk ofcomplications.

(2) Description of the Prior Art

In a known way, a prosthetic cardiac valve is fixed by stitching. Oneproceeds to stitching the prosthetic valve by means of separatedstitches between the prosthetic valve and the ring.

The surgeon thus often proceeds to stitching at least about twentyseparated stitches in order to fix the prosthetic cardiac valve. Inorder to carry out these stitches, he performs the fixing of the valvewith respect to the ring that remains at the level of the patient'sheart, in the way of a parachute, i.e. he draws rather long double wiresbetween the patient's ring and the prosthesis. Once he has passed thewires through all these stitching points, for example, about twentystitching points, he draws all the wires together, which permits him tobring the prosthetic valve close to the patient's ring, he can thusapply the prosthesis against the ring. He then fixes the wires by makinga knot and he cuts all the wires. This operation is long, takes usually45 to 60 minutes and is delicate.

Two usual stitching methods are known:

-   -   inserting at simple separate points: through the ring are passed        at regular intervals needles fitted on wires in the        ventricle-aorta or ventricle-auricle direction, depending on the        cardiac valve considered. On the other end of the wire is also        fitted a needle, which is passed through the collar, generally        of “Dacron”, of the prosthesis. Once all the wires have been        passed through the patient's ring and the collar of the        prosthesis, the prosthesis is lowered, in the way of a        parachute, into contact with the ring and the wires are tied.    -   inserting at separated points in the form of a U on pledgets:        the wire is with two needles and a 3 mm long and 1 mm wide        supporting felt. The two needles are passed in the        ventricle-aorta or ventricle-auricle direction, depending on the        cardiac valve considered, then passed through the collar of the        prosthesis, the prosthesis is lowered, in the way of a        parachute, into contact with the ring and the wires are tied.

These operations are time-consuming for a type of surgery in which timeis important. Indeed, while carrying out these gestures, the heart isstopped, and blood circulation as well as its oxygenation depend on theextra-corporal circulation (ECC).

Various attempts to accelerate the operational time have been made. Analternative to the traditional device for stitching a prosthetic valveon the patient's ring is a stent incorporating the prosthetic valve. Thestent is itself closed in the form of a cylinder having a diameter ofabout 8 mm, this stent is inserted through the femoral artery and ismoved upwards to the heart. The disadvantage is that this stent isnecessarily fixed in the patient's native valve, and that a propercutting of the patient's valve cannot be performed. The native valve isgenerally very hard because of the accumulation of calcium, and itswalls are porous and are no longer elastic. Placing the stent in thepatient's native valve is a bad solution for this tightness problem.This solution is reserved for patients who cannot be operated. Inaddition, the prostheses inserted into such stents are new, and there isno knowledge as to their longevity. On the other hand, the ancillarydevice according to the invention permits to very reliably use theprostheses that have been existing for a long time and the life time ofwhich has been proven.

The invention relates, as a matter of fact, to providing meanspermitting the practitioner to operate so-called non operable patients,often more than 75 years old, and who could become operable if theoperational time is highly reduced with respect to the state of the art.

Further attempts have been made while improving the stitching method.U.S. Pat. No. 6,413,274 B1 thus describes a device for placing, at thelevel of the patient's ring, a crown of clips implanted in radialdirections with respect to the axis of the patient's ring to which areconnected the ends of the wires inserted in the prosthetic valve. Thismethod allows a reduction of the operational time, the practitioner musthowever still carry out all the finishing of the stitching work. Inaddition, the clips are implanted at the periphery of the patient'sring, and a risk of tear of the tissues cannot be excluded. A documentU.S. Pat. No. 6,464,707 describes a similar system.

US2001/0031972 A1, in turn, describes an apparatus for placing aprosthetic valve through fastening with clips, which is designed so asto unfold the clips radially with respect to the axis of the patient'sring. These clips include, each, two tapping ends. The first one isstraight and is designed capable of perforating a collar the prostheticvalve includes, after radial extension of a clip holder. The othertapping end is bent and is designed capable of separating the tissuesduring the radial extension of the clip holder, then of perforating sameduring its deformation towards a closing position enclosing the tissuesin the vicinity of said collar, under the action of the translation of atube inserted into the tissues. It is obvious that the use of such adevice damages the tissues during the insertion of the tube in order toclose the bent end, and that the straight end is inserted at a veryshort distance from the surface of the patient's ring. Thus, in thesetwo areas there exists a risk of tear, which should absolutely beavoided. This solution does not guarantee a complete closing of the cliparound the prosthesis and the patient's ring, at the level of thetissues there is a fragile area in the vicinity of the two points of theclip when the latter is bent. The problem is that, as a matter of fact,this zone in which the clip is not fully closed is also the moststrained by the blood pressure. In short, the method using the deviceaccording to this document US2001/0031972 A1 does not permit to transfixthe patient's ring, but only to perform a simple hooking, with a highrisk of damaging the tissues.

Another document US2006/217744 describes foldable arms to implant astent in an artery or the like.

Another document WO 2005/048883 describes an apparatus for placing aprosthetic valve through fastening with clips. These clips have a firsttapping end in the prosthetic valve, and a second one in the patient'sring. These second one is anchored like a partially opened hook in thepatient's annulus, and there is, too, a risk of tear of the tissues.

Another documents US2006/212114, US2001/044656, WO97/30659 describemeans and methods of replacing a heart valve in a minimally invasivemanner.

SUMMARY OF THE INVENTION

The purpose of the invention is to cope with the disadvantages of thestate of the art, and to very substantially reduce the operational timeby providing the surgeon with an ancillary device that allows him toperform, in a fully reliable way for the patient and without any risk oftear for the tissues, the placing of a prosthetic cardiac valve withinabout 10 to 15 minutes, thanks to the use of an automated ancillarydevice for inserting and fixing a prosthetic cardiac valve.

The invention pretends to allow the automation of the insertion and theplacing of the prosthetic cardiac valve, in order to make them easierand to allow the practitioner to save time. The aim looked for is alsoto facilitate a robotized implanting, or first through a small path,where these operations become long and painful.

Of course, the development of a prosthetic cardiac valve is extremelydelicate and extremely long. Thus, the aim is not to substitute newmodels for the prosthetic cardiac valves existing on the market, but touse the valves which have proved reliable and which are hithertoaccepted by almost all patients.

To this end, the invention relates to an automated ancillary device forinserting and fixing by means of clips an annular body, namely aprosthetic cardiac valve, on a substantially annular resilient volume,said ancillary device including, coaxially fitted about a longitudinalaxis, means for receiving and supporting said annular body designedcapable of receiving the latter coaxially to its axis of rotation, meansfor radially unfolding about said longitudinal axis articulated clipsupports designed capable of bearing clips that are designed capable ofpassing through both a thickness of material belonging to such anannular volume and a thickness of material belonging to said annularbody under the action of longitudinal pushing means of said clipsupports with respect to said means for receiving and supporting,wherein it also includes means for gripping material of said annularvolume designed capable of radially retracting said material, andwherein said means for radially unfolding about said longitudinal axissaid articulated clip supports are designed capable of moving said clipsparallel to said longitudinal axis.

According to a feature of the invention, said means for radiallyunfolding about said longitudinal axis said articulated clip supportsare designed capable of moving said clips parallel to said longitudinalaxis, and include to this end an aggregate of pantographs each formed oftwo rods each articulated, at one of their ends, to one of said clipsupports and, at their other end, respectively to a nut guided in anouter tube and indexed in rotation on the latter, on the one hand, andto an ferrule, on the other hand, which nut and ferrule are bothinternally threaded and designed capable of cooperating with threads inopposite direction, which a screw with an axis designed capable of beingdriven by a rotary ring with an axis includes.

According to a feature of the invention, said gripping means are mountedcoaxially to said longitudinal axis.

The major advantage of the invention is to permit, through theimplementation of the ancillary device, a complete closing of each clipon itself, by enclosing in a durable way the various elements fastenedtogether by the clip, after having exerted a pulling force on one of theelements fastened together by the clip in order to secure the latteragainst any successive tear. In the preferred case of fixing aprosthesis on a resilient annular volume, such as a cardiac ring, theancillary device according to the invention permits to ensure that eachclip passes completely through the prosthesis and also through thisannular volume.

Further features and advantages of the invention will become clear fromthe following detailed description of the non-restrictive embodiments ofthe invention, with reference to the attached figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 represents, schematically and partially, a cross-sectional view,according to its longitudinal axis, of an ancillary device according tothe invention, shown provided with means for receiving and supporting,in the form of a bell, an annular body;

FIG. 2 represents, schematically and in perspective, the means forreceiving and supporting an annular body, in the form of a bell, of FIG.1;

FIG. 3 represents, schematically and from an end, the bell of FIG. 2;

FIG. 4 represents, schematically, partially and in cross-section, afirst position of a ancillary device according to the invention,including means for gripping inactivated material;

FIG. 5 is a view similar to the preceding one, representing a secondposition of the ancillary device of FIG. 4, in which these grippingmeans are activated under the action of a depression;

FIG. 6 is a view similar to the preceding one, representing a thirdposition of the ancillary device of FIG. 4, in which means for radiallypositioning the clips are separated from the longitudinal axis;

FIG. 7 is a view similar to the preceding one, representing a fourthposition of the ancillary device of FIG. 4, in which clip supports arebrought close to a resilient annular volume under the action of pushingmeans, for inserting clips into the latter;

FIG. 8 is a view similar to the preceding one, representing a fifthposition of the ancillary device of FIG. 4, in which said clip supportsare brought close to an annular body for making it integral, by means ofthe clips, with the annular volume;

FIG. 9 represents, schematically and in perspective, a clip made out of<<Nitinol>> at a first temperature;

FIG. 10 represents, schematically and in perspective, the clip of FIG. 9at a second temperature;

FIG. 11 represents, schematically and in longitudinal cross-section, themeans for gripping material of figures A to E;

FIG. 12 represents, schematically, an another clip shown at differenttemperatures.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The invention relates to an automated ancillary device 100 for insertingand fixing an annular body 200, namely, in a preferred application, aprosthetic cardiac valve, on a substantially annular resilient volume 23and including an opening. In fact, in a natural state, this resilientvolume, when it is formed by the patient's ring, generally has atriangular cross-section with rounded angles. This volume 23, after apreparation by the surgeon to remove very hard areas, is shaped and acylindrical tool, called phantom, is passed through it, which permits todefine the diameter of the prosthesis, the latter being generallycircular.

A preferred embodiment of the invention is shown in the figures.

The annular body 200 includes at least one revolving portion rotatingabout an axis of rotation. It is preferably formed of a prostheticvalve, or a biological valve. Such prostheses or valves are as follows:having a diameter from 19 to 33 mm, they permit, as regards the smallestones, the insertion through the center of an ancillary device having adiameter preferably smaller or equal to 13 mm, which at the end of theprocedure can be withdrawn in the same way. The biological prosthesesaccount for 60% of the currently implanted prosthetic valves. Theancillary device 100 according to the invention is designed for theplacing of a type of proven prosthesis, characterized by a high rate ofabsence of re-intervention, of about 90% over a 15 years' period.

The ancillary device 100 according to the invention permits a method ofplacing of the annular body 200 no longer by stitching as in the priorart, but by fastening with clips 21, which is perfectly safe in use andcan be performed with a high accuracy. The automated ancillary device100 constitutes a device for fastening an annular body 200, namely aprosthetic valve, in particular a cardiac valve, on a substantiallyannular resilient volume 23, namely a patient's ring prepared by asurgeon.

The ancillary 100 comprises a shaft 24. In the axis of this shaft 24, adevice 25, retractable in the way of an umbrella, preceded by an ogivalinsertion ferrule 1, is designed capable of being inserted, in closedposition, into the substantially annular volume 23.

This retractable device 25 is designed capable of being unfolded, namelyinside the patient's ventricle, below a partition formed by thesubstantially annular volume 23, namely a patient's ring, with respectto the upper side from which it is inserted.

The diameter size, with respect to a longitudinal axis D the ancillarydevice 100 includes, of the retractable device 25 is preferably smalleror equal to 13 mm. It is recalled that the diameter sizes of the usualprostheses are range from 25 to 33 mm for mitral valves and from 19 to27 mm for aortic valves.

The ancillary device 100 includes, designed capable of being mountedcoaxially about a longitudinal axis D:

-   -   means for receiving and supporting 8 an annular body 200, which        are designed capable of receiving the latter coaxially to its        axis of rotation, and of bringing it applied against the body        23,    -   means for radially unfolding 500, around this longitudinal axis        D, articulated clip supports 4. The latter are designed capable        of bearing clips 21. These clips 21 are designed capable of        passing through several thicknesses, i.e. both a wall of a        substantially annular volume 23, namely formed by tissues, and        the annular body 200, namely the prosthesis, under the action of        longitudinal pushing means 600. These longitudinal pushing means        600 result, under the action of a force exerted at the level of        a control handle 16 provided with a gripper 17, into bringing        the clip supports 4 closer to said means for receiving and        supporting 8, or also to the control handle of the ancillary        device 100.

The ancillary device 100 is thus designed to bind together asubstantially annular volume 23, namely formed the patient's ring, andan annular body 200, by means of a network of clips 21 designed capableof being closed around this substantially annular volume 23 and thisannular body 200, under the action of a force exerted on one or severalclip supports 4, on the one hand, or/and on these means for receivingand supporting 8, or under the action of a force exerted by the clips 21themselves, during a change of physical state.

These means for receiving and supporting 8, as can be seen in FIG. 1 or2, are preferably designed with a shape and size capable of receiving anannular body 200 formed by a prosthetic cardiac valve. They are namelyformed, in a version shown in FIG. 1, by a bell 8 capable of acting asan anvil, and which, in a particular version, includes means for guidingthe clips for their closing 800, as can be seen in FIG. 3.

In a preferred way, the network of clips 21 is annular, and rotatingabout the longitudinal axis D. It can also be star-shaped, centeredabout this same axis.

The quality of the fastening by clips is directly related to the properpositioning of the clips 21 supported by the clip supports 4, withrespect to the substantially annular volume 23. Indeed, if the diameteron which the clips 21 are placed is too close to the opening of thissubstantially annular volume 23, there exists a risk of tearing the wallof the latter. This substantially annular volume 23 is resilient, i.e.has some elasticity. According to the invention, the latter is used,when designing the ancillary device 100 capable of exerting a radialpulling force on the substantially annular volume 23, namely thepatient's ring, before performing the fastening by means of clips.

To this end, the ancillary device 100 according to the inventionincludes means for gripping 300 material, namely at the level of a wall,pertaining to the substantially annular volume 23, which are designedcapable of performing a radial retraction, towards its axis, of thematerial of the volume 23 in the vicinity of its opening.

Preferably, these gripping means 300 are mounted coaxially to thelongitudinal axis D.

As can be seen in FIG. 1, the gripping means 300 are formed, in apreferred embodiment, by a ring 10, and include suction means designedcapable of exerting a radial or/and axial depression at the level of thematerial of the volume 23 in the vicinity of its opening.

These suction means preferably consist of one or several grooves ororifices 13, provided for at the bottom of a rotation recess 15 designedcapable of receiving the volume 23 in its full thickness, each orifice13 being connected, through at least one channel, to a suction group sosized as to exert in said orifice or orifices 13 a depression with aradial or/and axial component. The radial depression is preferred, sinceit permits the radial retraction of the volume 23 until its free endrests in the recess 15. Preferably, as can be seen in FIG. 11, thisrecess 15 includes one or several resilient seals 14, designed so as toensure the tightness while the volume 23 is maintained under depressionat the bottom of the recess 15. In a particular variant embodiment, thering 10 itself can be made out of resilient material and ensure thistightness around the volume 23. In a preferred application, thedepression is calculated so as to permit a radial retraction of theradius of the volume 23 by a few millimeters, preferably by 2 to 3millimeters. The width of the recess 15 is, preferably, larger than 4millimeters.

It is obvious that the orifices 13 can be made in the form of grooves,because of the simplicity of their carrying out, they can also consistof points of depression, or the like, namely radially arranged in a stararrangement.

This possibility of retraction of the substantially annular volume 23,which the ancillary device 100 according to the invention provides, isparticularly important in the preferred application for heart surgery.It permits to prevent the patient's ring from being pierced by clipsover a small thickness close to its opening, thus exposing it to tearingwhen it is subjected to the forces of the blood flow.

The clips 21 must then be accurately positioned with respect to thesubstantially annular volume 23, at the points of fastening by clipsdetermined by the user.

To this end, the means for radially unfolding 500 articulated clipsupports 4 about the longitudinal axis D are arranged at the level ofthe retractable device 25. These means 500 include an aggregate ofpantographs 30 comprised, each, of two rods 3A, 3B, each articulated atone of their ends to one of the clip supports 4 and, at their other end,respectively to a nut 5 guided in an outer tube 6 and indexed inrotation on the latter, on the one hand, and to a ferrule 1, on theother hand, the nut 5 and the ferrule 1 being both internally threadedand designed capable of cooperating with threads in the oppositedirection, which a screw 2 with an axis D designed capable of beingdriven by a rotating ring 12 with an axis D includes.

The articulated clip supports 4 are preferably each articulated to rods3A, 3B forming together an articulated pantograph 30 extending radiallyaccording to a plane passing through the longitudinal axis D.

Preferably, as can be seen in FIG. 1, the shaft 24 of the ancillarydevice 100 includes an outer tube 6 with a longitudinal axis D. Thistube 6 constitutes means for guiding, at a first end, a tapped nut 5.This nut 5 is designed capable of circulating in the tube 6, and firstrotation-indexing means oblige this nut 5 to circulate onlylongitudinally according to the direction D. Preferably, these firstrotation-indexing means are formed by the conjugation of a longitudinalslit parallel to D, which the outer tube 6 includes, which slit isdesigned capable of cooperating with a radial pin, which the nut 5includes.

The nut 5 is provided with radial recesses and hinging means 41, namelypins, for permitting the free hinging of first rods 3A, which are inturn, each, fixed by means of pins with a view to the free hinging, atthe level of hinging means 40A, of a clip support 4. This nut 5cooperates, at the level of its internal thread, with a first thread ofa threaded spindle 2, designed capable of being driven in rotation, atthe end opposite this first end, by a rotary ring 12, namely a knurledring, through a pin 11, the rotary ring 12 being guided by the outertube 6 on which it is mounted so as to rest on it.

The threaded spindle 2 also includes a second threaded portion the pitchof which is in a direction opposite that of the first threaded portion,and which is designed capable of cooperating with an inner thread, whichthe insertion ferrule 1 includes, which ferrule is provided, like thenut 5, with recesses for articulated rods 3B at the level of hingingmeans 42, namely pins, rods 3B, which are each hinged, at the level ofhinging means 40B, to a clip support 4. The hinging means 40A and 40Bare distant from each other. Preferably, the lengths between the hinging41 and 40A, on the one hand, 42 and 40B, on the other hand, areidentical, and the axes of the hinging means 40A and 40B are equallydistant from the axis D. It is thus obvious that any rotational motionimparted by the rotary ring 12 to the threaded spindle 2 results intotranslations according to the direction D, but in opposite direction, ofthe nut 5 and the ferrule 1. Indeed, the latter are connected in ahinging way by the rods, can have no rotational motion about D, neitherwith respect to each other, nor with respect to the outer tube 6. Therods 3A and 3B can be unfolded or folded, and drive the clip support 4according to a radial movement, always parallel to the axis D, as can beseen in FIG. 6. In addition, because of this configuration, the radialmovement always occurs in the same plane perpendicular to the axis D.

The action of the means for radially unfolding 500, about thelongitudinal axis D, through unfolding the articulated pantographs 30thus permits to move the clip supports 4, and thus the clips 21 theysupport, exclusively parallel to the longitudinal axis D, in a preferredembodiment. The means for radially unfolding 500 also permits toaccurately position the clips 21 on a selected annular diameter. Ofcourse, the means for controlling these means for radially unfolding500, in particular at the level of a knurled rotary ring 12, canadvantageously be graduated.

Thus, by providing the clip supports 4 with equally long clips 21, it ispossible to control the accurate radial position of the tapping end thelatter include. The clips 21 are preferably double clips, i.e.including, connected to a heel designed capable of cooperating with aclip support 4, two parallel tapping legs perpendicular to this heel.They are preferably made out of titanium alloy. In an advantageousvariant, the clips 21 are made out of shape-memory <<Nitinol>> alloy, soas to spontaneously close after passing through the substantiallyannular volume 23 and the annular body 200. They are then capable ofbeing closed under the action of a shape-memory trigger, which can bethermal, electric, or mechanical. In the latter case, the bell 8 is nolonger absolutely necessary in the ancillary device during the closingof the clips 21, and is necessary only for bringing the annular body 200into its position of fastening by clips in the vicinity of the volume23.

It is obvious that the proper holding of the clips 21 is essential, isparticular when the ancillary device 100 is used in heart surgery. Theancillary device 100 permits to position the clips 21 absolutelyparallel to the axis of the substantially annular volume 23, accordingto which the axis D of the ancillary device is aligned. For a perfectholding at the moment of the closing of the clips 21, it has beendevised to make special clips with a large heel, i.e. with a height ofabout 2 mm, for clips with a total length of 9 mm, in a preferredembodiment.

The clips 21 arranged in the form of an annular beam can thus be broughtvery accurately into the insertion position in front of thesubstantially annular volume 23, and can then be inserted through thelatter, according to a relative movement with a direction D of the tube6 with respect to the substantially annular volume 23, thanks to theprevious action of the gripping means 300, which guarantees a sufficientmaterial cross-section in order to prevent any tear between each clip 21and the radial edge of the substantially annular volume 23 towards theaxis D.

The ancillary device 100 comprises, designed capable of being mountedcoaxially about the axis D, means for receiving and supporting 8 theannular body 200, which are designed capable of receiving the lattercoaxially to its axis of rotation. These means for receiving andsupporting are, preferably and as can be seen in FIG. 1, formed by arigid bell 8 coaxial to the axis D, and designed capable of being drivenlongitudinally by a pushing tube 9 with an axis D, at a first end ofthis tube 9.

This bell 8 includes, in a particular application in which the clips 21are folded by percussion during plastic deformation, second means forindexing the rotation 900 with respect to the outer tube 6 on which itis designed capable of sliding, namely under the action on the pushingtube 9. These means for indexing the rotation can preferably be formedby the combination of a pawl, which the bell 8 includes, as can be seenin FIG. 3, and a longitudinal groove, which the outer tube 6 includes.It is thus indexed in rotation, not only with respect to the tube 6, butalso with respect to the nut 5, at the clip supports 4 and at the clips21 themselves.

The ancillary device 100 includes, in a version implementing plasticallydeformable clips 21, means for longitudinally pushing 600 the clipsupports 4 with respect to these means for receiving and supporting 8.The pushing means 600 include a gripper 17 articulated on a movablehandle 16 designed capable of being mounted in an integral and indexedway with respect to the outer tube 6, this gripper 17 being designedcapable of applying a force according to the direction D to a pushingtube 9 designed capable of transmitting this force to the means forreceiving and supporting 8, in opposition to the clip supports 4, whichare fixed in position, through the nut 5, with respect to the outer tube6.

The pushing tube 9 is designed capable of being actuated, at its endopposite this first end, by a gripper 17 articulated at the level of ahandle 16. This handle 16 is designed capable of being made integralwith the outer tube 6, namely by means of an indexing button 18 providedwith springy restoring means 19 and with a holding spindle 20. Thepushing tube 9 is also designed capable of cooperating with a recess,namely a perforation, which the outer tube 6 includes.

It is obvious that a force in the direction D, applied to the gripper 17imparts a relative movement of the pushing tube 9 with respect to thethreaded spindle 2 and thus with respect to the clip supports 4. Thisforce is transmitted by the pushing tube 9 to the bell 8 bearing theannular body 200.

The longitudinal pushing means 600 are designed capable of cooperatingwith guiding means 800 for closing the clips 21, in the version ofclosing of the clips 21 through plastic deformation. These guiding means800 are incorporated in the means for receiving and supporting 8. Thelatter are angularly indexed with respect to the clip supports 4 byindexing means 900.

The bell 8 thus includes, on the side facing the clip supports 4 andfacing each of them over a given diameter, so-called diameter offastening by clips, means for guiding 800 the clips 21 for their closingthrough plastic deformation under the action of the impact of theselongitudinal pushing means 600. These guiding means 800 are formed, atthe level of a frontal face of the bell 8 by co-planar left machiningsin a plane P parallel to the axis D, facing each other and designedcapable of deforming towards each other the two points of each clip 21,these machinings are similar to those existing on an anvil of an officestapler, and are distributed over a frontal annular sector of the bell8, according to the diameter of fastening by clips. The longitudinaltravel distance of the longitudinal pushing means is calculated largerthan the distance separating the point of each clip 21 from the bell 8,so as to force each clip point to bend, under the pushing force, whileresting on the face nearest to the components fastened together byclips, here the annular body 200. It is obvious that, for means forguiding the clips 800 as can be seen in FIG. 3, each clip 21 folds ontoitself in the plane P defined by the corresponding guiding means 800.

Thus, the aggregate of clips 21 is inserted at once by an impact, whichbrings the bell 8 closer to the clip supports 4. The clips 21 passcompletely and successively through the substantially annular volume 23and the annular body 200, their points then bend on the guiding means800 and are folded closely against the face of the annular body 200 awayfrom the substantially annular volume 23, after each clip 21 hascompletely passed through the latter. The heel, which each clipincludes, maintained in its clip support 4, remains resting against thesubstantially annular volume 23.

It is obvious that each bell 8 is designed for a particular diameter offastening by clips, depending on the radial position of the means forguiding 800 the clips 21 for their closing. The same ancillary device100 can thus be used for several applications, it is enough to changethe bell 8 and to choose the one adapted to the required diameter. Thisis all the more easy since, as can be seen in the figures, the ancillarydevice 100 is designed with coaxial subsets inserted onto each other andvery easy to be dismantled, cleaned and maintained.

Indeed, as can be seen in FIG. 1, the ancillary device includes, alignedwith respect to the axis D, the threaded spindle 2, which the nut 5cooperates with. While moving radially away from the axis D, the nut 5is guided in the outer tube 6 on which the pushing tube 9 is guided,acting itself as guiding means, at its end located on the side of theclip supports 4, for the ring 10.

The exchange of a bell 8 is thus particularly easy, as well as that of aring 10, which can also be chosen of a size depending on theapplication.

A sequence of clips is shown from FIG. 4 to FIG. 8, it corresponds tothe case of the insertion of the ancillary device 100 without the bell8, of the penetration of the substantially annular volume 23 by theneedles 13, as can be seen in FIG. 4, of the retraction of the volume 23towards the axis D, as can be seen in FIG. 5, and, after unfolding ofthe clip supports 4, as can be seen in FIG. 6, of the insertion of theclips 21 into the substantially annular volume 23, as can be seen inFIG. 7. The operator then inserts the bell 8 provided with the annularbody 200, as can be seen in FIG. 8.

If the operator wants to use plastically deformable clips 21, heinstalls the removable handle 16 and the gripper 17 at the end of thepushing tube 9. He finally proceeds to impacting the clips 21 onto thebell 8 under the action of the pushing means 600.

If he wants to use shape-memory clips 21, he can at this stage, wherethe annular body 200 is maintained integral with the volume 23 by theclips 21, close them under the action of a modification permitting theirchange of state, and namely under the action of a rise in temperature.

Of course, the pushing means 600, here shown in a simplified form, canbe provided with effort reducers, namely with an eccentric or knucklemechanism, in the way of an office stapler.

The clips 21 are preferably deformed over a longitudinal travel distanceof about 2 mm. In the case of plastically deformable clips 21, alongitudinal impulse on the outer tube 6 permits, after fastening byclips, to uncouple the heels of the clips 21 from their recesses for theclip supports 4.

In the preferred case of using shape-memory clips, namely made out of<<Nitinol>>, the biocompatibility of which is proven, the bell 8 onlyserves for holding the annular body 200, and as a support at the base ofthe clip for the substantially annular volume 23 and the annular body200, and is not required for closing the clip 21, the closing of whichis brought about by a thermal or electric, or mechanical trigger, or thelike, which will be inserted so as to cover the bell 8, or instead ofthe latter.

According to the invention, these clips 21 made out of <<Nitinol>> aredesigned capable of passing from a first unfolded position at a firsttemperature to a second folded position at a second temperature higherthan the preceding one.

They can, in a reversible movement, pass from the second position to thefirst position by passing from the second temperature to the first one,thus permitting an easy ablation of the system, should such benecessary.

The shape-memory properties of <<Nitinol>> are then used during thepreparation of the clip 21 for its change in state and shape between twotemperatures: as can be seen in FIG. 9, at a first low temperature, i.e.in the range of 8° C., the clip 21 has a U-shaped with two substantiallyparallel legs, which will be inserted into the annular volume 23 and theannular body 200. As can be seen in FIG. 10, at a second temperature,which is higher than the first temperature, for example close to 30° C.,applied after complete insertion of the clip 21 into the latter, thelegs of the U are bent towards each other, thus enclosing the annularvolume 23 and the annular body 200.

The clips 21 advantageously include a heel designed capable of passingfrom a first folded position at a first temperature to a second unfoldedposition at a second temperature, which is higher than the precedingone.

In an another execution, this heel is designed capable of passing from afirst unfolded position at a first temperature to a second foldedposition at a second temperature, which is higher than the precedingone.

In every case, the clip 21 and the clips support 4 are designed toallow, during the change of the form of the heel, a good extraction ofthe clip 21 outside its clip support 4.

In a preferred execution, the heel is designed capable of passing from afirst position with a form like a “Z” or like a “S” or incurved at afirst temperature, as can be seen in FIG. 9, to a second straightposition, as can be seen in FIG. 10, at a second temperature, which ishigher than the preceding one.

It is also possible to use these shape-memory properties by providingthe heel, through which the clip 1 cooperates with the clip holder 4, atthe first temperature a corrugated shape so as to prop up this heel onfaces the clip holder 4 includes, and to thus ensure its perfect holdingin the latter, as can be seen in FIG. 9, and, at the second temperature,a straight shape permitting its release without friction from the clipholder, as can be seen in FIG. 10.

It is obvious that, thanks to the use of such clips made out of<<Nitinol>>, the bell 8 is not absolutely necessary and can bemaintained for acting as a counter-support. Indeed, the shape-memoryproperties alone already ensure the proper closing of the clip 21 on theannular volume 23 and the annular body 200 together. By maintaining thenthe body temperature close to 37° C., any reversibility of the shape ofthe clips 21 is prevented and their permanent fixing is thus guaranteed.

After fastening by means of clips, a reverse operation of the means forradially positioning 500 the clip supports 4 without their contents thenpermits to fold the latter along the threaded spindle 2, whileflattening the pantographs 30.

It is then possible to extract the ancillary device 100 through theopening of the substantially annular volume 23, which is then madeintegral with the annular body 200.

It is conceivable to carry out the automated ancillary and insertiondevice 100 for cardiac valve test in two forms, either for disposableuse in an embodiment including internally parts made of plastic or in afully re-usable form, for example made out of titanium alloy or/and ofstainless steel or the like, and thus sterilizable.

Such an automated ancillary device 100 can also easily be operated byremote control by a manipulator, since only elementary rotational andtranslational movements are implemented, at the level of the variouscontrol, adjustment and pushing means of this ancillary device. Theancillary device 100 can then also be provided with vision means, namelythrough optical-fibre endoscopy or the like.

The ancillary device 100 can also be provided with a device forrefilling clip 21.

The ancillary device 100 according to the invention can be prone tovariations according to results of the experimental surgery, and be usedfor applications other than heart surgery for which it has beendesigned. Though the example given here mainly relates to aortic andpulmonary implantations, this ancillary device can apply toimplantations on other rings, namely mitral, tricuspid rings, then withmodifications due to the direction of clearance of the prosthesis 200.Indeed, in the position of the aortic or pulmonary valve, the clearanceof the prosthesis is respectively in the aorta or the pulmonary arterylocated above the ventricle. In the position of the mitral or triscupidvalve, the clearance of the prosthesis is located in the left,respectively right ventricle. These modifications relate to the reversalof the clip supports 4, which will then be located, when referring toFIG. 1, left with respect to the ring 10, the means for receiving andsupporting 8, and the annular body 200, and no longer right with respectto same. The ring 10, the means for receiving and supporting 8, and theannular body 200 will then be in the opposite direction, i.e. from rightto left, compared to the one shown, i.e. from left to right, in FIG. 1.Likewise, the clip supports 4 will then be oriented in the oppositedirection.

Above and on the drawings is described a way where the clips are closedwith their first and second end, which go one in direction to another.But, in an other way to use the ancillary device 100 according to theinvention, the clips 21 can be used to deform their first and secondends opposite one from another, each in the direction outside of themain member of the clip. This other way allows a better covering of thegaps between the clips, and a good adaptation of the curvature.

In this case, these clips 21, namely made out of <<Nitinol>>, aredesigned capable of passing from a first folded position at a firsttemperature to a second unfolded position at a second temperature higherthan the preceding one.

A clip 21 usable in this other way is shown in FIG. 12, the clip in wireof “Nitinol” od diameter 0.5 mm has a form like a “U” in lowtemperature, with a radius of 1.65 mm at the head of the “U”, a distanceof 2.5 mm between the two legs of the “U” which are 11 mm long. At atemperature of 35° C., the legs are bent in the position 21Asemi-circular outside of the “U” with a radius of 5 mm an an openingangle of 126°. At a higher temperature of 37° C. or more, that is thehuman body temperature, the final bending in the position 21B has aradius of 4 mm and an opening angle of 157.5°, and is designed to ensurea good support to the prosthesis.

The best mode of the invention is described here. An other way to deformthe patient's ring before including the clips, with needles mounted onan expansible ring coaxial with the tube 6, is described in theapplications FR 07 60444 and FR 08 51346 of the same inventor.

1. Automated ancillary device for inserting and fixing by means of clipsan annular body, namely a prosthetic cardiac valve, on a substantiallyannular resilient volume including an opening, said ancillary deviceincluding, coaxially fitted about a longitudinal axis, means forreceiving and supporting (8) said annular body designed capable ofreceiving the latter coaxially to its axis of rotation, means forradially unfolding about said longitudinal axis articulated clipsupports designed capable of bearing clips, which are designed capableof passing through both a thickness of material belonging to such anannular volume and a thickness of material belonging to said annularbody under the action of longitudinal pushing means of said clipsupports with respect to said means for receiving and supporting,wherein it also includes means for gripping material of said annularvolume designed capable of radially retracting said material, andwherein said means for radially unfolding about said longitudinal axissaid articulated clip supports are designed capable of moving said clipsparallel to said longitudinal axis.
 2. Ancillary device according toclaim 1, wherein said means for radially unfolding about saidlongitudinal axis said articulated clip supports are designed capable ofmoving said clips parallel to said longitudinal axis, and include tothis end an aggregate of pantographs each formed of two rods eacharticulated, at one of their ends, to one of said clip supports and, attheir other end, respectively to a nut guided in an outer tube andindexed in rotation on the latter, on the one hand, and to an ferrule,on the other hand, which nut and ferrule are both internally threadedand designed capable of cooperating with threads in opposite direction,which a screw with an axis designed capable of being driven by a rotaryring with an axis includes.
 3. Ancillary device according to claim 1,wherein said gripping means are mounted coaxially about saidlongitudinal axis and are formed a ring with an axis including suctionmeans designed capable of exerting a radial or/and axial depression atthe level of the material of said volume in the vicinity of its opening.4. Ancillary device according to claim 1, wherein said means forradially unfolding about said longitudinal axis said articulated clipsupports are designed capable of constituting means for radiallypositioning said clips.
 5. Ancillary device according to claim 1,wherein said longitudinal pushing means include a gripper articulated ona handle designed capable of being mounted integral and indexed withrespect to said outer tube, said gripper being designed capable ofapplying a force according to said direction to a pushing tube designedcapable of transmitting said force to said means for receiving andsupporting, in opposition to said clip supports fixed in position withrespect to said outer tube.
 6. Ancillary device according to claim 1,wherein said longitudinal pushing means are designed capable ofcooperating with guiding means for closing said clips, which said meansfor receiving and supporting include, the latter being angularly indexedwith respect to said clip supports by indexing means.
 7. Ancillarydevice (100) according to claim 1, wherein said clips are double clipsmade out of shape-memory alloy and designed capable of passing from afirst unfolded position at a first temperature to a second foldedposition at a second temperature, which is higher than the precedingone.
 8. Ancillary device according to claim 7, wherein said clipsinclude a heel designed capable of passing from a first folded positionat a first temperature to a second unfolded position at a secondtemperature, which is higher than the preceding one.
 9. Ancillary deviceaccording to claim 1, wherein said clips are double clips made out ofshape-memory alloy and designed capable of passing from a first foldedposition at a first temperature to a second unfolded position at asecond temperature, which is higher than the preceding one. 10.Ancillary device according to claim 1, wherein said means for receivingand supporting are designed with a form and size capable of receiving anannular body formed by a prosthetic cardiac valve.